ASC’s lead product, Chondrofelt, (a medical device) is intended to repair articular cartilage defects. These defects are either caused by trauma or osteoarthritis. Chondrofelt will be used in conjunction with the surgical procedure known as microfracture. In microfracture, holes are punctured in the base of the defect into the underlying bone, with the aim of recruiting resident (autologous) stem cells from the bone marrow. Chondofelt will be placed in the defect to capture these stem cells to enhance repair. Chondrofelt will also be used with autologous stem cells harvested from the patient’s bone marrow.  In this two step procedure, bone marrow will be harvested from the patient and the stem cell population enriched. The cells will then be incubated in Chondrofelt for 1-2 hours and then implanted in the cartilage defect of the patient.

Chondrofelt will ensure that the patient’s stem cells reach the defect and remain in the defect, enhancing repair. There are approximately 500,000 cartilage repair operations performed in the United States annually.

MASCs lack the ability to cause a rejection response, and can thus be used allogenically. That is, cells harvested from a single donor can be expanded in culture and the expanded cells can be used to treat hundreds, thousands, or millions of patients.

PERIGEN (PERITONEUM)

ASC envisions its first product with MASCsTM to be PeriGen. PeriGen will regenerate peritoneum following abdominal surgery in order to prevent surgical adhesions. This involves injecting allogenic MASCs into the abdomen immediately prior to closing the incision. This is a significant market with approximately four million surgeries performed per year in the United States alone with no satisfactory product available.

CHONDROGEN (CARTILAGE)

ChondroGen is designed to regenerate articular cartilage (as opposed to “repair”) and subchondral bone in patients with cartilage damage typically resulting from sports injury, traumatic injury, or osteoarthritis. Current therapies focus on treating symptoms, which mainly result in pain relief but do not adequately repair the injury itself. Chondrofelt will result in temporary repair, probably postponing the need for an artificial joint prosthesis by 5 to 10 years. Artificial joint prosthesis, which lasts 10 to 15 years, is considered a poor treatment option for patients less than 50 years of age and is usually considered the treatment of last resort. ChondroGen being developed as a total medical solution to repair, replace, and regenerate cartilage in order to restore injured or chronic degenerated tissue back to normal.

ChondroGen will provide clear and sustainable competitive advantages. Of the estimated 1,000,000 cartilage injuries each year in the United States, approximately 500,000 require articular cartilage repair. ChondroGen will be a product where the Company will culture allogenic MASCs into an appropriate matrix. The matrix along with the MASCs will then be implanted by an orthopedic surgeon at the site of osteoarthritis. The MASCs in the ChondroGen will differentiate into both cartilage and bone when implanted into the damaged tissue site.

RHYTIGEN (CONNECTIVE TISSUE)

The Company will develop a product that will utilize MASCs to simply form connective tissue when injected under the skin. Like our other regenerative procedures with MASCs, the treatment should be nearly permanent, since the MASCs will form normal connective tissue that will always be there. The numbers of procedures done for the cosmetic treatment of wrinkles each year are in excess of five million treatments. Botox is one of the most popular procedures, with over two million of them performed annually. Additionally, injectable collagen and injectable hyaluronic acid have seen a significant level of acceptance in the past three years.

MENIGEN

ASC will develop a proprietary product that incorporates MASCs into a matrix for use as a universal allogeneic meniscus graft. Prior human studies with allograft meniscus transplants have shown no rejection of allograft material. This product will be placed in the meniscal tear to regenerate the meniscus as an alternative to meniscectomy: Basically,

  1.  the nurse will retrieve the MeniGen from the freezer,
  2. the physician will customize the MeniGen to fit the patient; and
  3.  the physician will replace the damaged meniscus.

After implantation, it is expected that the MASCs within the MeniGen will differentiate and produce fibrocartilage composing the meniscus, providing the ideal replacement for the torn tissue. There are approximately 850,000 meniscus procedures performed in the U.S. on a yearly basis.

OSTEOGEN (BONE)

The Company is developing a product that will utilize MASCs in either polylactic acid polymers or purchased porous bone substitutes as three-dimensional scaffolds for the healing of fractures, non-union fractures, and craniofacial defects. There are approximately one million operations performed per year to address this medical issue. After implantation, the matrix is designed to encourage proliferation and migration of resident osteoblasts to assist in the fracture repair. After implantation, it is expected that the MASCs within OsteoGen will differentiate into osteoblasts, providing the ideal replacement for bone without using metallic plates, rods, and, or screws.

DERMIGEN (SKIN)

ASC plans to develop a product utilizing MASCs to form the cell types in skin, fibroblasts in the dermis and keratinocytes in the epidermis. In addition, skin has two secondary structures, sweat glands and hair follicles, made of specialized cells for each. The most important secondary structure in skin is the sweat gland which regulates temperature. Hair follicles provide some sensation, but mostly they provide the textured appearance of skin that makes up the cosmetic appearance. There are approximately 500,000 burns each year that require medical treatment. There are about 160,000 people per year (mostly in nursing homes) that have decubitus ulcers. There this also an unknown number of orthopedic fractures (such as the distal tibia) that need soft tissue coverage

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